Interim Head of Regulatory Affairs (Diagnostics)

Our Client is a UK-based, well-funded and ambitious diagnostics company working on a range of in-vitro diagnostic tests, the first of which is now commercially available.

The US is understandably seen as a top-priority market, and work is currently underway with the aim of submitting and obtaining 510k approval for one particular product within the company’s pipeline.

The need has emerged for an Interim Head of Regulatory Affairs to ensure that the work done and the submission to be made to the FDA will meet the necessary requirements.

It is anticipated that the successful candidate will work closely with a yet-to-be appointed US-based expert who will have an existing network of contacts within the FDA and specific experience of face-to-face interaction with this critically important Authority.

This interim assignment is initially expected to be of 3-6 months duration, and is likely to demand 1-2 days per week.

This is an excellent and exciting opportunity in a small, ambitious and fast-growing company. The contribution to be made will be highly visible and of critical importance.

If this opportunity is a good fit with your own areas of experience and expertise, please make contact with Geoff Newman (Interea) as soon as possible.

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